Oral Colchicine Combined With Intravitreal Infusion of Dexamethasone, LMW Heparin and 5-FU for Management of Proliferative Vitreoretinopathy (PVR)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Shahid Beheshti University of Medical Sciences.
Recruitment status was  Recruiting
Information provided by:
Shahid Beheshti University of Medical Sciences
ClinicalTrials.gov Identifier:
First received: August 30, 2006
Last updated: June 25, 2008
Last verified: June 2008
To evaluate the efficacy of oral colchicine combined with intraoperative infusion of dexamethasone, low molecular weight heparin and 5-FU during vitrectomy for management of established proliferative vitreoretinopathy (PVR)

Condition Intervention Phase
Proliferative Vitreoretinopathy
Drug: oral colchicine, dexamethasone, low molecular weight heparin, 5-FU
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Shahid Beheshti University of Medical Sciences:

Primary Outcome Measures:
  • Retinal reattachment rate

Secondary Outcome Measures:
  • PVR recurrence,
  • macular pucker,
  • reoperation,
  • ocular hypotony,
  • visual acuity

Study Start Date: September 2006
Arms Assigned Interventions
Active Comparator: 1 Drug: oral colchicine, dexamethasone, low molecular weight heparin, 5-FU
Placebo Comparator: 2 Drug: placebo


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Cases with rhegmatogenous retinal detachment complicated by PVR grade C

Exclusion Criteria:

  • History of pars plana vitrectomy for PVR grade C
  • History of silicone oil injection
  • History of ocular trauma
  • Diabetic retinopathy
  • Glaucoma
  • Giant retinal tear
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00370760

Contact: Hamid Ahmadieh, MD +98 21 22585952 hahmadieh@hotmail.com

Iran, Islamic Republic of
Hamid Ahmadieh, MD Recruiting
Tehran, Iran, Islamic Republic of, 16666
Contact: Hamid Ahmadieh, MD    +98 21 22585952    hahmadieh@hotmail.com   
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
Principal Investigator: Hamid Ahmadieh, MD Ophthalmic Research Center of Shaheed Beheshti Medical University
  More Information

ClinicalTrials.gov Identifier: NCT00370760     History of Changes
Other Study ID Numbers: 8404 
Study First Received: August 30, 2006
Last Updated: June 25, 2008
Health Authority: Iran: Ethics Committee

Keywords provided by Shahid Beheshti University of Medical Sciences:
Oral colchicine
low molecular weight heparin

Additional relevant MeSH terms:
Vitreoretinopathy, Proliferative
Eye Diseases
Retinal Diseases
BB 1101
Dexamethasone 21-phosphate
Dexamethasone acetate
Heparin, Low-Molecular-Weight
Anti-Inflammatory Agents
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Antirheumatic Agents
Autonomic Agents
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Gastrointestinal Agents
Gout Suppressants
Hormones, Hormone Substitutes, and Hormone Antagonists
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 26, 2016